FDA Issues Label Change for Afluria Influenza Vaccine

Data reveal southern hemisphere formulation linked to febrile events in young children

By Beth Gilbert

HealthDay Reporter

MONDAY, Aug. 2 (HealthDay News) -- The U.S. Food and Drug Administration has updated the Warnings and Precautions sections of the Prescribing Information for the influenza virus vaccine Afluria, as the vaccine has been associated with an increased incidence of fever and febrile seizure in children younger than 5 years of age in Australia.

While the FDA issued the label change of CSL Ltd.'s influenza virus vaccine, the only formulation associated with these adverse events was the company's southern hemisphere formulation. Additional data on other available influenza virus vaccines indicate no increased rate of fever or febrile seizure for children in the southern hemisphere.

The FDA is requiring the company to conduct a study on the safety of their influenza virus vaccine to gain further insight into the febrile events recorded in the southern hemisphere. Although CSL will not be supplying U.S. customers with the 0.25 ml single-dose, pre-filled syringes, the company will provide U.S. customers with the 0.5 ml single-dose, pre-filled syringes and 5 ml multi-dose vials. The FDA encourages clinical practitioners and patients to report any adverse events associated with influenza virus vaccines to the Vaccine Adverse Event Reporting System.

According to an FDA safety alert, "various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia's regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised, and take part in the investigations."